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To Evaluate the Efficacy and Safety of Hearticelgram®-AMI in Patients With Acute Myocardial Infarction.

Primary Purpose

Acute Myocardial Infarction

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hearticellgram-AMI
Sponsored by
Pharmicell Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. As of the date of written consent, between 20 and 75 years of age
  2. Those with less than 50% of the left ventricular ejection fraction (LVEF) on echocardiography performed after percutaneous coronary intervention (PCI) (evaluated by investigator)

  3. Who has been identified as an acute myocardial infarction in any of the following on an electrocardiogram (12-lead electrocardiography, ECG) performed before PCI

    • ST-segment elevation 0.1 mV in two or more limb leads or
    • 0.2 mV elevation in two or more contiguous precordial leads indicative of acute myocardial infarction (AMI)
  4. Those identified as anterior wall MI
  5. Who meet the above criteria and have successfully reperfused within 72 hours after the onset of chest pain
  6. Who can conduct clinical trials according to the clinical trial protocol
  7. Who has consented in writing to voluntarily participate in this clinical trial (owner or legal representative)

Exclusion Criteria:

  1. Who have not been diagnosed with malignant blood diseases (acute myelogenous leukemia, acute lymphocytic leukemia, non-Hodgkins lymphoma, Hodgkins lymphoma, multiple myelopathy) within 5 years of screening criteria
  2. Patients with severe aplastic anemia
  3. Patients with solid cancers in their previous medical history (within 5 years)
  4. Patients whose blood serum AST/ASL rates are more than three times the normal maximum rate, and whose creatinine rates are more than 1.5 times the normal maximum rate (but AST in myocardial infarction patients can temporarily rise, thus, as decided by the researchers, if there is no damage to the liver function, the rise will not be taken into consideration)
  5. Patients who have implemented Coronary Artery Bypass Graft(CABG)
  6. Patients with chronic heart failure (patients with medical history of heart failure medical history at least three months before the occurrence of acute myocardial infarction)
  7. Patients who cannot proceed with cardiac catheterization
  8. Patients who had been continuously taking large doses of steroids (1mg/kg/day) or antibiotics for severe infections from one month prior to registration
  9. Patients who had major surgical operations, organ biopsy, or significant external injury as determined by the researcher, within three months before registration
  10. Patients who have head injuries or other external injuries after the development of myocardial infarction
  11. patients with stroke or transient ischemic attack within six months before registration, patients with history of central nervous system disease (tumor, aneurysm, brain surgery etc.)
  12. Patients with low survival ability after cardiopulmonary resuscitation within last 2 weeks.
  13. Patients with positive for HIV, HBV, HCV, Syphilis
  14. pregnant women or likely to be pregnant or lactating women
  15. Patients with drug abuser within last 1 year.
  16. Patients with participating other clinical trials with last 1 month.
  17. When the possibility of tumor occurrence is seen when the tester judges even one of the tumor marker tests during screening
  18. Who are judged to be inappropriate to participate in this test when judged by the examiner

Sites / Locations

  • Kangwon National University HospitalRecruiting
  • Chungnam National University HospitalRecruiting
  • Chonnam National University HospitalRecruiting
  • Yongin Severance HospitalRecruiting
  • Gachon University Gil Medical Center
  • Inha University Hospital
  • Catholic University of Korea, Seoul ST. Mary's Hospital.
  • Korea University Medicine
  • Severance Hospital, Yonsei University College of Medicine
  • Wonju Severance Christian HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Single dose of Hearticellgram-AMI

Arm Description

After implementing PCI, contemporary drug treatment is conducted. *Contemporary drug treatment is a general drug treatment (Unfractionated heparin, Low Molecular Weight Heparin, Glycoprotein llb/llla inhibitor, Aspirin, clopidogrel or Ticlopidine, Nitrate, ACE inhibitor or ARB, β-blocker, CCB, Diuretics, Statin, etc.)

Within 30 days (+ / -7 days) after aspirating bone-marrow, approximately 1×10^6/kg (refer to usage/dosage according to mass) of autologous bone marrow-derived mesenchymal stem cells are adminstered into the infarct coronary artery using balloon tipped catheter. Furthermore, contemporary drug treatment is conducted.

Outcomes

Primary Outcome Measures

LVEF amount of change
Left ventricle ejection fraction (LVEF) measured 13 months after the cell treatment (MRI measurement)

Secondary Outcome Measures

LVEF amount of change
Left ventricle ejection fraction (LVEF) measured 6 months after the cell treatment (MRI measurement)
Infarct size amount of change
Change in infarct size evaluated by MRI at 6 and 13 months compared to before administration
Left ventricle end systolic size change
Change in left ventricular end systolic size evaluated by MRI at 6 months and 13 months compared to before administration
Left ventricular end-diastolic size change
Change in left ventricular end diastolic size evaluated by MRI at 6 months and 13 months compared to before administration
Incidence of critical heart events
The incidence of major cardiac events (death, hospitalization for cardiac shock or heart failure, recurrence of myocardial infarction, occurrence of severe arrhythmias) within 24 months after administration
Heart rate variability change amount
Heart rate variability change at 13 months compared to before administration (24 hours Holter measurement)
Left ventricular local wall movement disorder index change
The amount of change in the left ventricular local wall movement impairment index evaluated by echocardiography at 6 and 13 months compared to before administration
N-terminal pro-brain natriuretic peptide (NT-proBNP) change
Changes in N-terminal pro-brain natriuretic peptide (NT-proBNP) at 6 and 13 months compared to before administration

Full Information

First Posted
July 25, 2012
Last Updated
October 21, 2021
Sponsor
Pharmicell Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01652209
Brief Title
To Evaluate the Efficacy and Safety of Hearticelgram®-AMI in Patients With Acute Myocardial Infarction.
Official Title
A Randomized,Open labEled, muLticenter Trial for Safety and Efficacy of Intracoronary Adult Human Mesenchymal stEm Cells Acute Myocardial inFarction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2013 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmicell Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Through the injection of Hearticellgram-AMI into acute myocardial infarction patients who are the primary targets of the drug, long term efficacy in the improvement of the left ventricle ejection fraction upon the first cell treatment is to be evaluated and compared with the current existing treatments (contemporary drug treatment). This study will also compare the efficacy and safety of single dose of hearticellgram-AMI.
Detailed Description
We are enrolling a patient who had successful conventional percutaneous coronary intervention after acute myocardial infarction. Patients are allocated to one of three groups (group1=comparator, group2= one dose of hearticellgram-AMI). single dose of hearticellgram-AMI have been attained new drug approval from MFDS (related to NCT01392105).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
After implementing PCI, contemporary drug treatment is conducted. *Contemporary drug treatment is a general drug treatment (Unfractionated heparin, Low Molecular Weight Heparin, Glycoprotein llb/llla inhibitor, Aspirin, clopidogrel or Ticlopidine, Nitrate, ACE inhibitor or ARB, β-blocker, CCB, Diuretics, Statin, etc.)
Arm Title
Single dose of Hearticellgram-AMI
Arm Type
Experimental
Arm Description
Within 30 days (+ / -7 days) after aspirating bone-marrow, approximately 1×10^6/kg (refer to usage/dosage according to mass) of autologous bone marrow-derived mesenchymal stem cells are adminstered into the infarct coronary artery using balloon tipped catheter. Furthermore, contemporary drug treatment is conducted.
Intervention Type
Biological
Intervention Name(s)
Hearticellgram-AMI
Other Intervention Name(s)
(Autologous bone marrow derived mesenchymal stem cells)
Primary Outcome Measure Information:
Title
LVEF amount of change
Description
Left ventricle ejection fraction (LVEF) measured 13 months after the cell treatment (MRI measurement)
Time Frame
13 months after the cell treatment
Secondary Outcome Measure Information:
Title
LVEF amount of change
Description
Left ventricle ejection fraction (LVEF) measured 6 months after the cell treatment (MRI measurement)
Time Frame
6 months after the cell treatment
Title
Infarct size amount of change
Description
Change in infarct size evaluated by MRI at 6 and 13 months compared to before administration
Time Frame
6, 13 months after the cell treatment
Title
Left ventricle end systolic size change
Description
Change in left ventricular end systolic size evaluated by MRI at 6 months and 13 months compared to before administration
Time Frame
6, 13 months after the cell treatment
Title
Left ventricular end-diastolic size change
Description
Change in left ventricular end diastolic size evaluated by MRI at 6 months and 13 months compared to before administration
Time Frame
6, 13 months after the cell treatment
Title
Incidence of critical heart events
Description
The incidence of major cardiac events (death, hospitalization for cardiac shock or heart failure, recurrence of myocardial infarction, occurrence of severe arrhythmias) within 24 months after administration
Time Frame
Within 24 months after the cell treatment
Title
Heart rate variability change amount
Description
Heart rate variability change at 13 months compared to before administration (24 hours Holter measurement)
Time Frame
13 months after the cell treatment
Title
Left ventricular local wall movement disorder index change
Description
The amount of change in the left ventricular local wall movement impairment index evaluated by echocardiography at 6 and 13 months compared to before administration
Time Frame
6, 13 months after the cell treatment
Title
N-terminal pro-brain natriuretic peptide (NT-proBNP) change
Description
Changes in N-terminal pro-brain natriuretic peptide (NT-proBNP) at 6 and 13 months compared to before administration
Time Frame
6, 13 months after the cell treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: As of the date of written consent, between 20 and 75 years of age Those with less than 50% of the left ventricular ejection fraction (LVEF) on echocardiography performed after percutaneous coronary intervention (PCI) (evaluated by investigator) Who has been identified as an acute myocardial infarction in any of the following on an electrocardiogram (12-lead electrocardiography, ECG) performed before PCI ST-segment elevation 0.1 mV in two or more limb leads or 0.2 mV elevation in two or more contiguous precordial leads indicative of acute myocardial infarction (AMI) Those identified as anterior wall MI Who meet the above criteria and have successfully reperfused within 72 hours after the onset of chest pain Who can conduct clinical trials according to the clinical trial protocol Who has consented in writing to voluntarily participate in this clinical trial (owner or legal representative) Exclusion Criteria: Who have not been diagnosed with malignant blood diseases (acute myelogenous leukemia, acute lymphocytic leukemia, non-Hodgkins lymphoma, Hodgkins lymphoma, multiple myelopathy) within 5 years of screening criteria Patients with severe aplastic anemia Patients with solid cancers in their previous medical history (within 5 years) Patients whose blood serum AST/ASL rates are more than three times the normal maximum rate, and whose creatinine rates are more than 1.5 times the normal maximum rate (but AST in myocardial infarction patients can temporarily rise, thus, as decided by the researchers, if there is no damage to the liver function, the rise will not be taken into consideration) Patients who have implemented Coronary Artery Bypass Graft(CABG) Patients with chronic heart failure (patients with medical history of heart failure medical history at least three months before the occurrence of acute myocardial infarction) Patients who cannot proceed with cardiac catheterization Patients who had been continuously taking large doses of steroids (1mg/kg/day) or antibiotics for severe infections from one month prior to registration Patients who had major surgical operations, organ biopsy, or significant external injury as determined by the researcher, within three months before registration Patients who have head injuries or other external injuries after the development of myocardial infarction patients with stroke or transient ischemic attack within six months before registration, patients with history of central nervous system disease (tumor, aneurysm, brain surgery etc.) Patients with low survival ability after cardiopulmonary resuscitation within last 2 weeks. Patients with positive for HIV, HBV, HCV, Syphilis pregnant women or likely to be pregnant or lactating women Patients with drug abuser within last 1 year. Patients with participating other clinical trials with last 1 month. When the possibility of tumor occurrence is seen when the tester judges even one of the tumor marker tests during screening Who are judged to be inappropriate to participate in this test when judged by the examiner
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JIYEOUN JEONG
Phone
82-2-3496-0134
Email
jyjeong@pharmicell.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jeonghan Yoon, Ph.D. M.D.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeonghan Yoon, Ph.D. M.D.
Organizational Affiliation
Wonju Severance Christian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kangwon National University Hospital
City
Chuncheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bongki Lee
Facility Name
Chungnam National University Hospital
City
Chungnam
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-ok Jeong
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Geun Ahn
Facility Name
Yongin Severance Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duk-gyu Cho
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Individual Site Status
Terminated
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Terminated
Facility Name
Catholic University of Korea, Seoul ST. Mary's Hospital.
City
Seoul
Country
Korea, Republic of
Individual Site Status
Terminated
Facility Name
Korea University Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Terminated
Facility Name
Severance Hospital, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Terminated
Facility Name
Wonju Severance Christian Hospital
City
Wŏnju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeonghan Yoon

12. IPD Sharing Statement

Learn more about this trial

To Evaluate the Efficacy and Safety of Hearticelgram®-AMI in Patients With Acute Myocardial Infarction.

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